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Challenges of the Market
The vast cauldron-like crater of a caldera marks a geological hot spot, a place where elemental forces
once surged to Earth’s surface in a massive volcanic eruption, leaving behind compelling evidence of their
destructive power. Caldera Health exists to help identify cancerous “hot spots” www.calderahealth.co.nz
Jim Watson
February, 2014
Confidential to Caldera Health Limited
CALDERA
HEALTH
CALDERA
HEALTH
Who are we?
Skill
factors
We outsource
•
•
•
Supported by a
strong Board
•
Confidential to Caldera Health Limited
Legal
Patent, and
Financial
services
Clinical
CALDERA
HEALTH
The Vision
• A molecular diagnostic business providing a range of cancer
diagnostic tests based on gene expression profiling.
• A game-changing technology platform.
• First targets are to diagnose prostate cancer and the
staging or progression of the disease.
• Achieve global reach by partnership with an established
multinational diagnostic company.
Confidential to Caldera
3
CALDERA
HEALTH
The Opportunity Environment
• Prostate cancer is becoming the most frequently diagnosed cancer in
men globally
• It is a disease of many phenotypes
• The PSA (prostate specific antigen) test, is controversial due to the
inability to diagnose all prostate cancer or distinguish cancer from
other non-cancerous prostatic diseases
• Rather than defining a cancer by its tissue of origin and morphology
under the microscope Caldera seeks to define prostate cancer by its
genetic properties
Confidential to Caldera
4
Start-ups are difficult to value
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NPV can be described as the “difference amount” between the sums of discounted: cash inflows and cash
outflows. It compares the present value of money today to the present value of money in the future, taking
inflation and returns into account.
Investors can calculate risks and likely returns. Straightforward to make investment decisions.
Confidential to Caldera Health Limited
CALDERA
HEALTH
Diagnostic markets are mature
• Molecular technologies are like a tsunami sweeping through
many business fields
• Diagnostic markets are not isolated from the changes coming
but are slow to respond
• That’s because they have already a significant investment tied
up in current diagnostic laboratories
• Often in the form of equipment and long-term reagent contracts
• So investors look at start-ups and see the problems with the
birth of a new molecular science business
Confidential to Caldera Health Limited
CALDERA
HEALTH
So make the proposition understandable
Confidential to Caldera Health Limited
CALDERA
HEALTH
Caldera is a science-based business
• We develop RNA biomarkers for gene transcript profiling to
diagnose cancer
• We seek a urine or blood diagnostic and prognostic test to
replace DRE’s and biopsies
• We are going through a scientific process to get there
Confidential to Caldera Health Limited
CALDERA
HEALTH
We start with Gleason scoring
Healthy prostate gland
Confidential to Caldera Health Limited
Prostate adenocarcinoma
Prostate cancer – glands filling in
Confidential to Caldera Health Limited
CALDERA
HEALTH
Many large nucleoi are seen here in the nuclei
of sheets of cells in prostatic adenocarcinoma.
We are completing our first clinical study
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The study involved screening 88 RNA biomarkers
Using tissue samples from donor prostate gland tissue with
Gleason scores from 5 – 10
From each donor tissue we selected a cancerous tissue sample
and an adjacent “normal” tissue sample
And analysed RNA expression profiles in cancerous versus
healthy samples
Confidential to Caldera Health Limited
To get to a Clinical Validation Study
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HEALTH
• Our process for selecting RNA biomarkers is unique
• Our next generation sequencing (NGS)platform for simultaneous multibiomarker analysis is unique
• We developed a novel bioinformatics tool with Biomatters Ltd to
specifically process and analyse the output data from NGS
• We discovered random selection of RNA biomarkers can be linked based
on biology
• This has implications in other cancers
Confidential to Caldera Health Limited
We monitor other technology out there?
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HEALTH
• Real time PCR technology used,for example, by Genomic Health,
Illumina, Pacific Edge
• RT-qPCR is limited in its fluorescence detection range, compared to
NGS based sequencing detection methods
• The cost per sample analysis will be lower than achieved by RT PCR
• And we file new patents on our processes and continually evaluate
other’s patents
Confidential to Caldera Health Limited
Investment cash flow is everything
Consistent
financial plan

Hiring and
retaining staff
Steady R&D
progress
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Investor
comfort

All start-ups struggle with this single issue – investors impatient for investment returns – many don’t survive
Confidential to Caldera Health Limited
The impatience of market perception
Too much science
Not enough
marketing
Confidential to Caldera Health Limited
CALDERA
HEALTH
CALDERA
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It’s an evolutionary process
R&D focus to get product line
established – What’s there to
market at the start?
Growth of business development and
marketing – A tangible product to market
From a science base to a corporate culture
Confidential to Caldera Health Limited
Corporate growth
necessary as product is
market – by company or
partner
There are common threads to all market questions
R&D focus to get product line
established – What’s to market?

Growth of business development and
marketing – A tangible product to market
Corporate growth
necessary as product is
market – by company or
partner
Are there others doing this?
Yes – academic groups and other companies
Why do we believe we are leaders?
Academics focused on seeking communication through peer
review
Companies seek communication through are market focused
Start-ups seek both? Why doesn’t PBRF recognise patents as
communication?

Our technology platform is unique.
We are unaware of any group using a NCS platform for
cancer diagnostics
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
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We can migrate the technology to other cancer diagnostics
Key Aspirations
First to market with an accurate prostate cancer test that provides both
diagnostic and prognostic applications;
First to market with a high volume routine diagnostic assay for a cancer
utilising next generation sequencing;
Strong patents to protect the technology